PreClinical CROs – Why, When, Who, and How?

When I started my company 7 years ago, I knew I would eventually need HR support and capabilities. I didn’t want to do it myself for a couple reasons . . . I didn’t have the experience or knowledge in HR (Nor do I want it, no offense to any HR friends!), and I didn’t have the set-up/capabilities to be able to do it. I ended up choosing an outside company and outsourced all of my HR needs/functions to them. Easy right? Nope! I had to consider . . . Do I really need them? When do I engage them? Who should I choose? How do I initiate and oversee them?

It’s the same thought process a pharma/biotech/med device company has when considering engaging a preclinical CRO to tackle their pivotal animal safety (and sometime efficacy) studies. Do we really need them or can we tackle this ourselves? When shall we start the process? There are so many choices, which CRO is right for us? Once engaged, how do we manage them and maintain control over our data/our program?

Benefits of Outsourcing (Why)

A solid preclinical program will go a long way in helping the sponsor company set up their Phase 1, 2, and 3 Clinical trials!

Preclinical development programs require a large amount of time and money.

Implementing and maintaining an accredited vivarium takes many resources.

To qualify for regulatory submission, the tests must be conducted per GLP (Good Laboratory Practice) conditions, which also takes additional resources.

Efficacy, early-on pharmacokinetic studies, and some acute non-GLP safety studies are often times conducted in-house by the study sponsor because there are fewer regulations, animals, and resources required, as compared to GLP studies.

Rather than spending the time, resources, and money to establish GLP conditions, it’s often times much more efficient to put the burden on the CRO who is already set-up and qualified to perform such studies.

When?

Since the preclinical phase can be so costly, try to take advantage of savings opportunities by good planning and implementation. Begin with your goal in mind, and then work backwards. Don’t rush the decision or the time-frame. Confirm the types of studies, study design, timelines, and budget before engaging a CRO.

Who?

There are a number of preclinical CROs and choosing the right one for your company can be a bit overwhelming. As with anything, I think word-of-mouth and referrals is the best place to start. Discuss with your colleagues and other companies who they have used and had success with. Don’t stop here though.

  • Attend trade-shows and speak with various CRO representatives
  • Research online
  • Read publications
  • Visit the CRO facilities
  • Request the results of recent FDA audits, 483s, etc
  • Obtain CVs for the study director(s)
  • Assess their Quality Assurance program

How?

Once you have engaged a CRO, it’s time to plan! Take this slow and don’t cut corners.

  • Identify a primary administrative and technical contact for the Sponsor company and the CRO
  • Sponsor should design a plan for monitoring and managing the study
  • Study timelines should be determined in advance and agreed upon by both parties
  • Sponsor and CRO should hold regular project team meetings
  • Regular sponsor visits (sponsor should try to attend the first day of dosing)
  • Sponsor audits
  • Perform interim data reviews
  • Upon completion of the study, Sponsor and CRO should set a timeline for report writing, review, and revision

Toto's Tips

  • Discuss the preclinical program early on and determine the need for a preclinical CRO.
  • Don’t rush the CRO selection process . . . there are many choices and many factors that determine WHO is right for YOU.
  • Don’t hand off your study to the CRO. You, as the sponsor company are ultimately responsible for the study, so stay involved from start to finish. Don’t lose the control.